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A Double-Blind, Placebo-Controlled, Parallel Group Comparison Study of Effects of Daily Ingestion of Shiikuwasha (Citrus depressa Hayata) Juice on Blood Pressure.

A Double-Blind, Placebo-Controlled, Parallel Group Comparison Study of Effects of Daily Ingestion of Shiikuwasha (Citrus depressa Hayata) Juice on Blood Pressure. - Effects of Daily Ingestion Shiikuwasha (Citrus depressa Hayata) Juice on Blood Pressure.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000024575
Enrollment
40
Registered
2016-10-27
Start date
2016-10-28
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy adults

Interventions

Daily ingestion of 95 ml of shiikuwasha juice for 8 weeks. Daily ingestion of 95 ml of placebo beverage for 8 weeks.

Sponsors

Hokkaido Information University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Subjects whose SBP in a clinic is >=130 mmHg and <160 mmHg. 2. Subjects who agree to participate in this study with a written informed consent.

Exclusion criteria

Exclusion criteria: 1. Subjects who are under physician's advice, treatment and/or medication for hypertension. 2. Subjects who have (or suspected) secondary hypertension such as chronic glomerulonephritis, pyelonephritis, primary aldosteronism, phaeochromocytoma, Cushing's syndrome, hyperthyroidism, etc. 3. Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, and/or affected with infectious diseases requiring reports to the authorities. 4. Subjects with major surgical history relevant to digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc. 5. Subjects with unusually high and/or low blood pressure and/or abnormal hematological data. 6. Subjects with severe anemia. 7. Pre- or post-menopausal women complaining obvious physical changes. 8. Subjects who are at risk of having allergic reactions to drugs or foods (especially citrus fruits). 9. Subjects regularly take medicine, functional foods and/or supplements (peptide, acetic acid, GABA, geniposidic acid, flavonoids, sesamin, chlorella, olive leaves, garlics, dietary fiber, tomatoes, folic acid, long pepper extract, etc.) which potentially affect the blood pressure. 10. Heavy smokers, alcohol addicts or subjects with disordered lifestyle. 11. Subjects who donated either 400ml whole blood within 12 weeks (men) /16 weeks (women) or 200ml whole blood within 4 weeks or blood components within 2 weeks prior to the current study. 12. Pregnant or lactating women or women expect to be pregnant during this study. 13. Subjects who currently participate in other clinical trials or participated within the last 4 weeks prior to the current study. 14. Any other medical and/ or health reasons unfavorable to participation into the current study judged by the principal investigator.

Design outcomes

Primary

MeasureTime frame
Systolic and diastolic blood pressure at 4 and 8 weeks after ingestion of test meals.

Secondary

MeasureTime frame
TC, LDL-C, HDL-C, TG, fasting plasma glucose, HbA1c, body weight, BMI, body fat percentage.

Countries

Japan

Contacts

Public ContactDir. Prof. Jun NISHIHIRA, M.D., Ph.D.

Hokkaido Information University Health Information Science Center

nishihira@do-johodai.ac.jp011-385-4430

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026